Number and quantities of reference standards (RS) needed for the quality
control of drugs are increasing, bringing great pressure to the calibration and
using company. This manuscript summarized the four generations for the development of RS
including physical RS, paper atlas, substitute RS and electronic databases. The
advantages and disadvantages of each generation were summarized. The concept of
digital RS (DRS) was proposed based on this, and summed up the definition,
advantages, and technical architecture of DRS. The 10 characteristics of five
aspects of the DRS were discussed including digital, multi-dimension,
big data, cloud computing, internet, internet of things, sharing,
multi-terminal, intelligence, and compliance certification. Then, the necessity
of its formation and application in the medicine holistic quality control of
internet plus era was discussed in this manuscript.
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